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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, BASF opens lab in Mumbai; Evotek president and CEO to resign; more...
Wilmington, NC (Dec. 15)-AAIPharma and CORTRIA (Boston) signed a deal granting CORTRIA the right to use AAIPharma’s “ProCR” controlled-release, oral drug-delivery technology in conjunction with CORTRIA’s TRIA-662 drug candidate. The ProCR technology reflects AAIPharma’s efforts to develop safe, cost-effective, and easy-to-manufacture formulation offerings. TRIA-662 is CORTRIA’s lead drug candidate in Phase II clinical development for dyslipidemia.
Craigavon, UK (Dec. 1)-The UK Medicines and Healthcare products Regulatory Agency (MHRA) completed a successful inspection of Almac Clinical Services’s Durham, North Carolina, operations. This procedure was the final inspection of the group’s main sites for clinical supplies (which include the Craigavon and Audubon, Pennsylvania, facilities) within the past four months. MHRA found the Durham site to be fully compliant with EU Good Manufacturing Practices.
Ludwigshafen, Germany (Dec. 9)-BASF opened an applications laboratory for pharmaceutical excipients and active ingredients in Mumbai, India. The new laboratory will allow BASF to meet the requirements of the Asian pharmaceutical industry for technical support more quickly. The site will allow BASF to provide customers with advice about functional aspects of products, optimizing formulations, and improving production conditions.
Dublin, Ireland (Dec. 12)-Elan is realigning some of its functions to direct additional investment towards its pipeline. The company decided to close its offices in New York and Tokyo during the first quarter of 2009. Elan will eliminate several positions and will modify its commercial activities related to its “Tysabri” treatment for Crohn’s disease.
Frankfurt, Germany (Dec. 1)-Evonik Degussa reports that its “AEROSIL” R 972 Pharma, a fumed silica exicpient, complies with the new monograph for “Hydrophobic Colloidal Silica” as published in the United States Pharmacopeia–National Formulary (USP 31–NF 26, 2nd Supplement, June 2008). The new USP/NF monograph took effect Dec. 1, 2008. The product has complied with the European Pharmacopoeia monograph since June 2006.
Lugano, Switzerland (Dec. 10)-Helsinn’s drug-product manufacturing facility in Dublin, Ireland, Helsinn Birex Pharmaceuticals, recently obtained an authorization for Manufacture of Investigational Medicinal Products (IMP) for products for human use from the Irish Medicines Board. The IMP license enables Helsinn Birex Pharmaceuticals to package, test, store, and release material for use in clinical trials. Since 2007, the company has invested in packaging and labeling equipment and facilities to enable it to perform both primary and secondary packaging of such products.
Loures, Portugal (Dec. 11)-Hovione agreed to acquire Pfizer’s (New York) Loughbeg, Ireland, active pharmaceutical ingredients (API) site. The site manufactures intermediates for the “Lipitor” drug’s API. The deal is scheduled to be complete by early April 2009. Hovione Cork will employ 70-80 staff and will, during the next 24 months, be transferring products from its Loures site and validating processes for new compounds in expectation of drug approval. Hovione will continue to provide manufacturing services for Pfizer.
Lund, Sweden (Dec. 10)-MIP Technologies entered into a collaboration with Sanofi-Aventis (Paris) for the development of new molecularly imprinted polymers (MIPs) for the analysis of pharmacologically active peptides from plasma samples. MIP Technologies will use several of its patented molecular imprinting methods to develop the polymers. Using MIPs for selective recognition of peptides and proteins is a novel area that will open up the technology to various applications in the diagnostic, pharmaceutical, and biopharmaceutical industries, according to MIP.
Research Triangle Park, NC (Dec. 10)-Patheon, a global provider of drug-development and manufacturing services to the international pharmaceutical industry, opened its new US headquarters and analytical laboratory facilities in the vicinity of Research Triangle Park (RTP), North Carolina. In addition to the new US headquarters facility, Patheon opened a new pharmaceutical development laboratory in RTP. This laboratory will support Patheon’s current US-based pharmaceutical development operations in Cincinnati and will initially offer stability studies, validation testing, and analytical chemistry services.
Kenilworth, NJ (Dec. 12)-Schering-Plough received marketing approval from the US Food and Drug Administration for its “PEG-Intron” (peginterferon alfa-2b) and “Rebetol” (ribavirin, USP) combination therapy for previously untreated chronic hepatitis C patients older than two years of age. The approval represents the first and only approved peginterferon in combination with ribavirin for treating pediatric hepatitis C, according to the company.
Aliso Viejo, CA (Dec. 10)-Valeant Pharmaceuticals International signed a definitive agreement to acquire Dow Pharmaceutical Sciences (Petaluma, CA), a privately held dermatology company that develops topical products on a proprietary basis and for pharmaceutical and biotechnology companies. The transaction enhances Valeant’s dermatology franchise in the United States through the acquisition of Dow Pharmaceutical’s newly approved product and a pipeline of five dermatology products. Under the terms of the agreement, Valeant will pay Dow $285 million, subject to certain closing adjustments. Approximately $8 million in cash will be retained from current Dow accounts, making the net amount paid $277 million.
Somerset, NJ (Dec. 12)-Alfacell, a biopharmaceutical company, announced that Lawrence A. Kenyon, its president, chief financial officer (CFO), and corporate secretary, resigned. Kenyon will remain on the board of directors of Alfacell and will also serve as acting president, CFO, and corporate secretary until at least Jan. 31, 2009. Kenyon accepted a position as executive vice-president of finance at Par Pharmaceutical, effective Dec. 15, 2008.
Hamburg, Germany (Dec. 10)-The drug development company Evotec announced that its president and chief executive officer (CEO) Jörn Aldag will resign, effective Dec. 31, 2008. Mario Polywka, chief operating officer, and Klaus Maleck, CFO, will jointly lead the company until a permanent successor is announced.
San Diego (Dec. 15)-Metabasis Therapeutics, a biopharmaceutical company, announced that Paul Laikind resigned as the company's president and CEO. He will continue to serve as a member of the board of directors. Mark D. Erion, chief scientific officer (CSO), executive vice-president of research and development, and a member of Metabasis’ board of directors, has been named president, CEO, and CSO.
Bothell, WA (Dec. 16)-The specialty pharmaceutical company SCOLR Pharma announced that Daniel O. Wilds resigned as CEO and as a member of its board of directors, effective Dec. 12, 2008. The existing executive management team will manage the company on an interim basis.
Rockville, MD (Dec. 16)-US Food and Drug Administration Commissioner Andrew von Eschenbach sent a memo to FDA staff announcing his intention to retire on January 20, 2009, according to an AP report. President-elect Barack Obama will appoint a new commissioner; see the recent blog post on PharmTech Talk about the potential appointees. http://blog.pharmtech.com/?p=686
York, England (Dec. 16)-Xceleron, a contract research organization, appointed Michael Butler president and CEO. Before joining Xceleron, Butler served as president and CSO at Aptuit.